- Integra LifeSciences (Boston, MA)
- …work experience is required. + A minimum of 2-4 years' experience in a medical device , pharmaceuticals, Quality / Regulatory Compliance, or other cGMP ... to advance patient outcomes and set new standards of care. **SUMMARY** The Quality Control Technician II will be responsible for performing Quality Control… more
- Cook Medical (Winston Salem, NC)
- …or- BS degree in same with 3 years relevant experience- Knowledge of medical device quality and regulatory systems - Ability to work independently and ... document design and/or process changes required for the maintenance of released medical devices. Responsibilities - Serve as technical and project leader for product… more
- Takeda Pharmaceuticals (Boston, MA)
- …patients with immunologic, hematologic, and other complex diseases. The Global Regulatory Device Labeling Strategy Lead (Senior Manager) Plasma-Derived Therapies ... Global Device Sub team to ensure that regulatory device labeling requirements are met for...and/or high complexity products (including combination, Software as a Medical Device , and standalone medical … more
- Catalent Pharma Solutions (Kansas City, MO)
- …+ 10+ years of relevant experience in pharmaceutical or medical device manufacturing, quality or regulatory , general business management, technical ... development, analytical research and development, project scale-up, product manufacturing, quality , validations, and regulatory + Experienced contract negotiator… more
- GE HealthCare (Cleveland, OH)
- …teams with documentation creation and updates; build your knowledge of medical device quality and regulatory guidelines + Develop and maintain ... at least 4 years of prior experience in technical writing, preferably in the medical industry or a related area + Aptitude to develop clinical and anatomical… more
- Kelly Services (Valencia, CA)
- …with business stakeholders within a cross-functional matrix environment. * 5+ years Class III Medical Device Company in Regulatory Affairs. * Experience with ... * **Product Labeling:** Collaborate cross functionally to ensure compliance with global medical device labeling regulations by overseeing the creation and… more
- Organon & Co. (Jersey City, NJ)
- …and review of documentation to ensure compliance with applicable Medical Device Regulations and internal Organon requirements. Sr. Quality Engineer ( ... cGMP and quality issues related to pure medical devices and the device constituent of... regulatory agency inspections with focus on relevant device regulations and Quality system requirements. +… more
- AbbVie (North Chicago, IL)
- …Instagram, YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description The Manager, Medical Device Quality - Software will act as the ... IL and report directly into the Senior Manager of Medical Device Quality . + Leads...app launches and market expansions. + SaMD/SiMD SME for regulatory / notified body inspections as needed + Lead… more
- AbbVie (North Chicago, IL)
- …YouTube, LinkedIn and Tik Tok (https://www.tiktok.com/@abbvie) . Job Description Purpose: The Manager, Medical Device External Quality is part of AbbVie's ... Assurance group and reports to the Senior Manager, Medical Device External Quality . The...internal stakeholders to ensure compliance with defined specifications and regulatory requirements. The position also supports Quality … more
- Pentax Medical (Montvale, NJ)
- …benefits program and generous Paid Time Off and Holiday policy. Want More INFO? The Medical Device , Senior Quality Engineer will lead and implement ... determining root causes and effectively implement the remediations. Responsibilities of Medical Device , Senior Quality Engineer + Utilizing… more
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